The use of medical catheters and probes has become an effective method for treating many types of diseases. In general, a suitable catheter or tubular probe is inserted into a body lumen of the patient (vascular or non-vascular) and navigated through the body lumen into a desired target site. Using this method, virtually any target site in the patient's body may be accessed. In certain treatments, it is desirable to secure the catheter or probe in some manner so that proper positioning and placement is maintained during the treatment, such as in some urinary incontinence treatments.
Urinary incontinence is one of the most prevalent conditions of the lower urinary tract, particularly, stress urinary incontinence (hereinafter SUI) which affect a significant amount of people. SUI is the loss of small amounts of urine associated with movements, such as coughing, sneezing, laughing, and exercise that cause increased pressure on the bladder based on increased intra-abdominal pressure. Some SUI treatment includes the delivery of energy to and/or through the urethral wall by precisely placing an elongated probe having an energy delivery element within the urinary tract. These probes usually have an anchoring member, such as an inflatable balloon, at a distal portion of the probe that sits in a patient's bladder, and a locking device at the proximal portion of the probe that is placed against the patient's external urethral orifice or urinary meatus, thereby securing the probe and the energy delivery member in a desirable position within the urethra. During these treatments, minimizing movement of the probe relative to the desired treatment site in the urethra and/or paraurethral region is desirable.
In the past, various devices have been used for securing the positioning a catheter or probe relative to a treatment site, such as urologic bladder balloons. While known bladder balloons may hold indwelling catheters (e.g. Foley-type) from “falling out” of a bladder over a period of time by readily adapting to the bladder and body structures, and further preventing urine leakage, these balloons also allow axial displacement of the catheter relative to the balloon (i.e. cuffing) and a relative large range of axial displacement of the catheter within the urethra. Cuffing refers to the balloon tendency to fold over on itself or shift toward the bladder end of an indwelling catheter. The application of axial force to the indwelling catheter may cause cuffing and deformation of the bladder balloon and further causes axial movement of the catheter within the urethra, even when the balloon still sits within the bladder preventing expulsion from the patient. Thus, these known bladder balloons do not resist axial movement of the catheter relative to the balloon or relative to a desirable treatment site within the urthera and/or paraurethral region. Further, the known conforming urologic bladder balloons do not provide a prompt and sharp tactile feedback to the user or physician when the balloon reaches or locates the bladder neck, particularly when low force is applied to the balloon. Because these balloons are conforming and readily adaptable to body structures, the feedback is usually difficult to notice when low force is applied.
Accordingly, there is an ongoing need to provide for a more suitable anchoring balloon that minimizes axial translation of a catheter or probe, when the catheter or probe is positioned at a desired treatment site and axial force is applied to the catheter or probe. Further, there is an ongoing need for a more suitable anchoring balloon that resists cuffing of the balloon or axial displacement of the catheter or probe relative to the balloon. Additionally, there is an ongoing need for a more suitable anchoring balloon that provides a prompt and sharp rise in tactile feedback to the user or physician that signals the location of the balloon within a body structure or cavity when low force is applied.